• Investigate the history and requirements for validation
• What is validation?
• Regulatory requirements and expectations
• Understanding terms and the application of validation
  • Discuss the terms used
  • Evaluate the key stages of validation
  • Use the basic 'V' model for a simple approach
  • View a CD video and answer questions
  • How far does Good Engineering Practice go towards meeting compliance?
• Use case studies to explore the causes and implications of non compliant validation
• Analyse real scenarios
• Determine suitable actions for workplace improvements

Day 2

• Identify how GAMP® guidance was developed and the reasons behind it
• Regulatory requirements
• Technological innovation
• Interpretation of rules and regulations
• Review the Life Cycle approach and phases, including: Life cycle concepts; concept, project and retirement
• Practical examples based upon GAMP® categories of software
• Operational phases including:
• Handover
• CAPA
• Change management
• Security 
• System administration
• Latest terminology and common themes including, the relationship between qualification terminology and GAMP® 5 activities
• V model approach for IT systems and process control systems
• Categories of software, hardware and the validation approach
• Introducing Quality Risk Management
• An overview of Quality Risk Management
• Description of the risk assessment process including sample risk assessments
• Develop understanding of guidance for supplier activities
• Consider help for suppliers
• Describe regulated company activities to assure computerised system compliance
• Elements to achieve compliance
• Regulatory approach to audits and non-compliance
• Areas particularly vulnerable to non-compliance for manufacturers, and supplier considerations
• Review other GAMP® 5 guidance articles and appendices including:
• Guidance on efficiency improvements 
• Appendices: 
• Management
• Development
• Operation
• Special Interest Topics
• Other General Appendices

Day 3

• Understand the regulation 21 CFR Part 11 
• What the requirements are
• Why have the regulation?
• Identify key terminology used in the regulation
  • Terms and definitions
• Lifecycle of a document
  • Electronic
  • Hard copy
  • Records
  • What is in and out of scope?
  • Premises and equipment
• Links to validation
  • Validation requirements for computer systems
• Training
  • Requirements
  • Qualifications and experience
• Management of systems
  • For open and closed systems
  • Physical and logical controls
• Signatures
  • Signature/record linking
  • Their uniqueness
  • Biometrics
• Controls
  • Password ageing
  • Procedures
  • Management responsibilities
• Understand FDA Part 11 Guidance for industry
  • Latest thinking and guidance
• Describe the GAMP approach to 21 CFR Part 11 compliance
  • Links with GAMP and risk assessment
  • Use GAMP risk assessment to assess a potential real scenario
• Recall problems encountered by companies applying the rule
  • Potential problem areas
  • Case studies
  • Differing scenarios/FDA warning letter reviews

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